BIOSIMILARS BASICS

Mylan has been committed to increasing access to medicine since our founding nearly 60 years ago. In all regions of the world where barriers prevent proper treatment, care and access, Mylan is committed to setting new standards in healthcare.

In 2018, we sold approximately 59 billion doses of medicine, most of which were in the forms of tablets, capsules and injectables. More and more, however, we are helping patients in yet another category – biosimilars. A biosimilar is a biologic medicine - unlike conventional drugs made up of small chemical compounds, biologics are complex products, typically proteins, made with active substances derived from living organisms, such as cells. Biosimilars offer FDA-approved off-patent competition. That means patients and healthcare professionals can rely upon the safety and effectiveness of a biosimilar product, just as they would the already-approved brand version of the biologic, called the reference product.

Here are five facts:

1

There’s No Clinically Meaningful Difference Between Reference Biologics and Biosimilars

Biologics represent the cutting edge of medical science and have become the standard of care for many devastating and debilitating diseases such as cancer, diabetes and rheumatoid arthritis. Due to their complexity, biologics can be expensive and, in some cases, out of reach for patients.

Enter biosimilars. Biosimilars are biologic medicines. According to regulatory authorities, there are no clinically meaningful differences between a biosimilar and its reference product in terms of safety and efficacy. While variations in all biologics are normal and expected, they must remain within a permitted range for the drug to be approved.

Today, biosimilars are approved and available in more than 70 countries, including the U.S., and their use has generated more than 700 million patient days of clinical experience.

2

Biosimilars Offer an Opportunity to Provide Greater Access to Biologics

When biosimilars are approved for use and are able to enter the market, competition may be able to reduce medicine prices, meaning more patients have access to this important therapy and health systems can procure more medicines without increasing their budgets. Of the top 20 costliest drugs in the world, 12 are biologics or insulins. Of those 12 biologics, Mylan has nine biosimilars or insulin products on the market or in the pipeline. By offering competitive biosimilar alternatives to expensive biologics, Mylan is committed to helping ensure that patients have better access to the medicine they need.

3

Mylan Also Helps Patients in Low- and Middle-Income Countries Have Access to Biologics

Mylan continues to pursue efforts to provide medicines everywhere, including countries in Africa, Asia, Latin America and other emerging markets. This is often where medicine is needed most and where access is challenged.

To date, Mylan has regulatory approval for biosimilars and insulin analogs in more than 65 countries.

4

Mylan Has a Strong Biosimilars Portfolio

Our global portfolio includes biosimilars referencing many of the best-selling biologics worldwide and focuses primarily on the areas of oncology, immunology, endocrinology, ophthalmology and dermatology. Following years of innovation and R&D, Mylan offers a diverse biosimilars portfolio that includes 20 biosimilars and insulin analogs on the market or in development. Further, Mylan has more than 100 marketing authorizations for biosimilar and insulin analog products worldwide.

5

Governments and Payors Can Benefit from Biosimilars

Biosimilars hold great promise to offer governments and payors sustainable solutions to manage healthcare budgets through off-patent competition to costly reference biologics. It's one of the reasons we work with other stakeholders to improve access to biosimilars by breaking down restrictive policies and other barriers to entry. Because of their complexity, biologics typically represent a large cost burden for patients, governments and payors. Yet, despite a number of originator biologics coming off patent, there are numerous policy and market-related barriers that can delay biosimilars from entering the market.

We collaborate with policymakers to remove these barriers and support regulations that create a sustainable biosimilars market that increases patient access and creates market competition. Our efforts to date have helped drive important policy changes in Canada, France, Ireland, Italy, the Netherlands, Portugal, the U.K and the U.S. Much more work remains to remove further policy barriers, but Mylan remains committed to building a robust biosimilars market to better serve patients.